Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia

A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues (R0) or macroscopic tumor residues < 1cm (R1)) followed by hyperthermia against normothermia intraperitoneal intraoperative chemotherapy with paclitaxel

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Key information

Conditions

Peritoneal Carcinomatosis Abdominal Neoplasms Adnexal Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Peritoneal Diseases Peritoneal Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age ranged between 18 and 75 years old;
histopathologic confirmation of peritoneal carcinomatosis from epithelial ovarian cancer (stage IIIc- FIGO (International Federation of Gynecology and Obstetrics));
Karnofsky index > 70 or performance status ≤2;
informed consent form filled out correctly.

Exclusion criteria

unfulfillment of inclusion criteria;
extraabdominal metastasis or stage IV FIGO (liver, lung, bone, etc);
concomitance of another malignant neoplasm;
renal, hepatic or cardiovascular dysfunction;
intolerance during the treatment; - (6) refusal to participate in the study.

Treatment and study plan

paclitaxel

Drug

Radical surgery-peritonectomy

Procedure

Primary outcomes

The Grouped Miller and Payne (MP) System for Pathological Response: G1 (Minimal Changes and < 30% Cells Tumour Reduction That Includes MP G1-G2), G3 (Microscopic Foci, Cells Tumour Reduction up to >90% That Includes MP G3-G4) and G5 (no Residual Tumour)

Time frame: The biopsies were taken before and after the treatment (intraperitoneal intraoperative chemotherapy for 60 minutes) and then they were analysed by two blinded pathologists.

Histopathology scoring system to assess response, previous and post intraperitoneal intraoperative chemotherapy. Compare cancer cellularity of the biopsy (before treatment) with the other biopsy (after treatment).

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2017
First posted: Apr 15, 2016
Registry last updated: Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed